RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:

Freedom from progression [ Time Frame: From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Biochemical failure by the ASTRO definition [ Time Frame: From randomization to the date of PSA failure per the ASTRO definition or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Biochemical failure by the Phoenix definition [ Time Frame: From randomization to the date of PSA failure per the Phoenix definition or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Disease-specific survival [ Time Frame: From randomization to the date of death due to prostate cancer or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Local progression [ Time Frame: From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Distant metastases [ Time Frame: From randomization to the date of metastastic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Overall survival [ Time Frame: From randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Incidence of "acute" toxicities [ Time Frame: Toxicity occurring less than or equal to 180 days from the start of radiation. ] [ Designated as safety issue: No ]

Time to "late" 3+ toxicities [ Time Frame: Toxicity occurring >180 days from the start of radiation. ] [ Designated as safety issue: No ]

Change in health-related quality of life from baseline as measured by EPIC, EQ5D, and AUA-SI [ Time Frame: From randomization to 2 timepoints: 1) 4 months (early) after intiation of therapy and 2) 2 years (late) after initiation of therapy. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and external beam radiotherapy [ Time Frame: Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Compare morbidity and quality of life of patients treated with these regimens.

Determine the feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT.

No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site

No major medical or psychiatric illness that would preclude study therapy

No hip prosthesis

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Prior neoadjuvant hormonal therapy allowed provided the following are true:

Therapy was initiated within 2-6 months of study enrollment

Therapy was no more than 6 months in duration

Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration

No concurrent hormonal therapy

Radiotherapy

No prior pelvic radiotherapy

Surgery

No prior radical surgery for prostate cancer

No prior transurethral resection of the prostate

No prior cryosurgery

Other

No prior transurethral needle ablation of the prostate

No prior transurethral microwave thermotherapy of the prostate

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063882